medical Class I Updated 2021-11-17

ELLUME LTD recalls Ellume COVID-19 Home Test

Recalled Product

Ellume COVID-19 Home Test


Hazard / Issue

Due to a higher rate of false positive test results.

Issued by

FDA

Affected States: MN, NY, PA, RI, UT, WA
Lot/Code Info: Catalogue number I-SRS-C-01 Master Lot Numbers: 21047-4; 21047-5; 21089-1; 21117-1; PF06Z-H; 21099-1; 21124-1; 21125-1; PF03X-H; PF057-H; PF05W-H; PF069-H; PF06E-H; PF06N-H; PF06Z-H; PG080-H; PG08H-H; PH08X-H;
View official government recall

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